US Meningitis Outbreak: should there have been tighter regulations?

The United States has recently witnessed an outbreak of fungal meningitis, a rare and non-contagious form of the disease. According to the Centers for Disease Control and Prevention (CDC), 105 people across a total of nine states have been infected and the number will probably rise. The affected people were contaminated by an epidural steroid injection called methylprednisolone acetate, used to cure various conditions including arthritis, blood disorders, eye conditions and certain cancers. The particular product that is linked to the disease was manufactured by New England Compounding Center (NECC), a pharmacy based in Massachusetts. As its name suggests, NECC is a compounding pharmacy. For those of you who are unfamiliar with the term, it refers to a pharmacy that creates customized medication for patients for whom manufactured pharmaceuticals do not work.

Physicians in the US are starting to rely more and more on products from compounding pharmacies either because they are not available otherwise or are available at a much lower price than those produced by major drug manufacturers. A big concern here is that the Food and Drug Administration (FDA) has little or no control over compounding services. Typically, all pharmacies are regulated by the state where they are located, but regulations vary depending on the particular state. The FDA has tried to oversee these pharmacies by developing rules for compounding but unfortunately these were turned down by the U.S. Supreme Court in 2002.

NECC has announced a voluntary recall of all products that were compounded at the facility in Framingham, Massachusetts. According to its website, the FDA is working closely with the CDC and state partners to the outbreak among patients who had received the steroid injection. The association is currently conducting additional testing to confirm the exact species of the fungus. The association has also recommended that both healthcare professionals and consumers not use any product that was produced by NECC.

In light of this outbreak, the question many will ask is: Should compounding pharmacies be regulated by government administration? But before that, another question: How much does supervision contribute to the safety of a drug? Also, do Asia's pharmacies and regulatory bodies have anything to learn from this case? If you are interested in discussing these issues with industry experts, consider attending the BioPharma Asia Convention 2013 this coming March. For our Pharma Trials World Asia conference track, the speakers will be discussing regulatory challenges in Asia. Hopefully, they will answer any questions about government regulations in Asian pharma.

To get a more in-depth view about the US meningitis outbreak, please visit the following links:

Meningitis outbreak: Your questions answered (CNN)
FDA Statement on Fungal Meningitis Outbreak
Multistate Meningitis Outbreak Investigation (CDC)

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